Procedures for handling returned goods MCQs With Answer

Introduction:
This concise guide covers procedures for handling returned goods MCQs with answer tailored for B.Pharm students. It explains key concepts such as return authorization, quarantine, documentation, batch traceability, quality control inspection, stability considerations, disposition decisions, and regulatory compliance under GMP. Emphasis is placed on practical steps: receiving returns, recording chain of custody, sampling for analysis, issuing credit notes, and safe destruction or reconditioning. These topics help pharmacy students understand pharmaceutical returns handling, returned goods investigation, root-cause analysis, and documentation requirements essential for drug safety and inventory reconciliation. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of placing returned pharmaceutical products into quarantine?

• To create storage space in the warehouse
• To immediately re-distribute the products
• To prevent mixing with saleable stock pending investigation
• To mark items for disposal without review

Correct Answer: To prevent mixing with saleable stock pending investigation

Q2. Which document typically authorizes acceptance of a customer return in a regulated pharmaceutical supply chain?

• Purchase order
• Return Merchandise Authorization (RMA) or Return Authorization
• Invoice only
• Packing slip with no additional approval

Correct Answer: Return Merchandise Authorization (RMA) or Return Authorization

Q3. Which action is most appropriate when a returned batch shows broken seals on packaging?

• Return it to sale immediately after re-labeling
• Quarantine and investigate for potential contamination or tampering
• Discard without documentation
• Apply new seals and ship back to customer

Correct Answer: Quarantine and investigate for potential contamination or tampering

Q4. What is a critical record to check for traceability when handling returned goods?

• Supplier’s marketing brochure
• Batch/Lot number and manufacturing records
• Employee payroll records
• Salesperson’s route map

Correct Answer: Batch/Lot number and manufacturing records

Q5. Under GMP, who is typically responsible for the disposition decision of returned pharmaceutical products?

• Warehouse loader
• Quality Assurance (QA) or Qualified Person (QP)
• Sales representative
• Customer service agent

Correct Answer: Quality Assurance (QA) or Qualified Person (QP)

Q6. If a returned drug is within expiry and unopened with intact packaging, what is the usual next step?

• Destroy immediately
• Reintegrate into saleable stock after QA inspection and documentation
• Ignore and leave in quarantine indefinitely
• Sell at discounted price without inspection

Correct Answer: Reintegrate into saleable stock after QA inspection and documentation

Q7. Which of the following is NOT a reason to reject reuse of a returned pharmaceutical item?

• Compromised sterility
• Expired beyond shelf-life
• Intact sealed packaging with verified batch and expiry
• Evidence of adulteration or tampering

Correct Answer: Intact sealed packaging with verified batch and expiry

Q8. What testing is commonly performed on returned drugs before disposition?

• Microbial limits, assay/potency, and visual inspection
• Only weight measurement
• Employee drug screening
• Color of the shipping box

Correct Answer: Microbial limits, assay/potency, and visual inspection

Q9. Which process documents the financial adjustment for a returned product?

• Quality audit report
• Credit note or debit memo and updated inventory records
• Batch manufacturing record
• Label reconciliation sheet

Correct Answer: Credit note or debit memo and updated inventory records

Q10. In cold-chain pharmaceuticals, what is essential when handling returns?

• Ignore temperature logs during return
• Review temperature excursion records and maintain cold-chain conditions
• Store at ambient temperature without documentation
• Use the fastest courier regardless of temperature control

Correct Answer: Review temperature excursion records and maintain cold-chain conditions

Q11. What is a key step in investigating customer complaints associated with returned goods?

• Delete the customer complaint record after one day
• Perform root cause analysis and record corrective/preventive actions (CAPA)
• Immediately issue a refund without investigation
• Return the product to the customer without questions

Correct Answer: Perform root cause analysis and record corrective/preventive actions (CAPA)

Q12. Which regulatory concept governs safe handling and documentation of returns in pharmaceutical manufacturing?

• Good Manufacturing Practice (GMP)
• Building codes
• Traffic regulations
• Food service guidelines

Correct Answer: Good Manufacturing Practice (GMP)

Q13. What should be included on the quarantine label for returned goods?

• Only product price
• Product name, batch number, date of return, and quarantine status
• Employee personal notes
• Customer’s home address

Correct Answer: Product name, batch number, date of return, and quarantine status

Q14. When are returned samples sent to the laboratory?

• Only when a customer demands it
• When QA determines analytical testing is necessary to decide disposition
• Never; all returns are discarded
• Only for controlled drugs

Correct Answer: When QA determines analytical testing is necessary to decide disposition

Q15. Which disposition is appropriate for a returned product confirmed to be counterfeit?

• Reintegrate into saleable stock
• Segregate, notify regulatory authorities, and destroy per procedures
• Return to customer with apology
• Use for internal testing without documentation

Correct Answer: Segregate, notify regulatory authorities, and destroy per procedures

Q16. How should returned controlled substances be handled differently?

• Handle like over-the-counter returns
• Follow strict chain-of-custody, regulatory reporting, and qualified witness destruction if required
• Allow any employee to remove them from quarantine
• Donate to third parties

Correct Answer: Follow strict chain-of-custody, regulatory reporting, and qualified witness destruction if required

Q17. What is the role of the Batch Manufacturing Record (BMR) during returned goods investigation?

• Provides irrelevant marketing information
• Helps verify production details, deviations, and original QC test results for the returned batch
• Is used to set retail price
• Controls warehouse lighting

Correct Answer: Helps verify production details, deviations, and original QC test results for the returned batch

Q18. For expired returned products, which action is commonly required?

• Restock without checking
• Dispose according to regulatory and environmental procedures with documentation
• Sell them at local markets
• Use them as training samples without records

Correct Answer: Dispose according to regulatory and environmental procedures with documentation

Q19. Which record ensures financial and inventory reconciliation after processing returns?

• Marketing campaign plan
• Inventory ledger and accounting credit note
• Employee attendance sheet
• Delivery route map

Correct Answer: Inventory ledger and accounting credit note

Q20. What is “reconditioning” in the context of returned pharmaceutical goods?

• Discarding all returned packaging
• Restoring product presentation or packaging after QA approval, without affecting quality
• Changing the formula of the product
• Mixing different batches to make a new product

Correct Answer: Restoring product presentation or packaging after QA approval, without affecting quality

Q21. Who must approve destruction of a pharmaceutical batch that failed testing after return?

• Quality Assurance and authorized witness per policy
• Any warehouse staff
• Customer returning the product
• Marketing manager

Correct Answer: Quality Assurance and authorized witness per policy

Q22. What is the importance of photographs and documentation during initial receipt of returned goods?

• They replace the need for laboratory testing
• They provide evidence of condition, support investigation, and preserve chain-of-custody
• They are only for social media
• They are optional and rarely useful

Correct Answer: They provide evidence of condition, support investigation, and preserve chain-of-custody

Q23. How long should records of returned goods investigations typically be retained?

• One week
• As specified by regulatory requirements and company policy, often several years
• Never retained
• Only until the next inventory count

Correct Answer: As specified by regulatory requirements and company policy, often several years

Q24. Which factor increases the likelihood that a returned product cannot be reintroduced into the supply chain?

• Unopened tamper-evident packaging
• Evidence of temperature excursion affecting stability
• Correct batch number documentation
• Valid return authorization

Correct Answer: Evidence of temperature excursion affecting stability

Q25. What should be done when a returned product is associated with an adverse drug reaction report?

• Ignore the adverse report if the product is unopened
• Initiate pharmacovigilance procedures and forward information to safety/QA teams
• Return the product to stock immediately
• Discard the report and only process the return

Correct Answer: Initiate pharmacovigilance procedures and forward information to safety/QA teams

Q26. Which personnel are typically involved in returned goods assessment?

• Only sales staff
• QA, QC, warehouse, regulatory affairs, and sometimes production
• External customers only
• Only the delivery driver

Correct Answer: QA, QC, warehouse, regulatory affairs, and sometimes production

Q27. What is the role of a Certificate of Analysis (CoA) in returned goods evaluation?

• It is irrelevant for returns
• It provides original QC results to compare with retest data and support disposition
• It is used to label the shipping box
• It is required only for cosmetics

Correct Answer: It provides original QC results to compare with retest data and support disposition

Q28. Which step reduces risk of diversion when handling returned bulk API containers?

• Storing them in unlocked areas
• Strict access control, documented chain-of-custody, and secure quarantine
• Mixing different APIs together
• Ignoring container seals

Correct Answer: Strict access control, documented chain-of-custody, and secure quarantine

Q29. How should returns from clinical trial supplies be managed?

• Like retail returns without special controls
• Follow clinical trial pharmacy procedures, accountability records, and sponsor instructions
• Return to general inventory immediately
• Discard without record

Correct Answer: Follow clinical trial pharmacy procedures, accountability records, and sponsor instructions

Q30. What is the advantage of having a defined returned goods SOP in a pharmaceutical company?

• Creates ambiguity in handling returns
• Ensures consistent handling, regulatory compliance, traceability, and clear responsibilities
• Makes returns slower without benefits
• Only helps the marketing department

Correct Answer: Ensures consistent handling, regulatory compliance, traceability, and clear responsibilities

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com